A magnetic device that improved the function of the lower esophageal sphincter helped to reduce patients' exposure to esophageal acid, improved their symptoms of gastroesophageal reflux disease (GERD), and reduced their reliance on proton-pump inhibitors, according to an industry-funded prospective study.
Robert A. Ganz, MD, from Minnesota Gastroenterology in Plymouth, and colleagues reported the 3-year results of their 5-year study online February 20 in the New England Journal of Medicine.
The device's manufacturer was involved in the design of the prospective, multicenter study. Thirteen centers in the United States and 1 in the Netherlands enrolled 100 patients aged 18 to 75 years with a 6-month history of GERD and partial response to proton-pump inhibitors in the first 9 months of 2009. The patients were fitted with bracelet-like magnetic beads that circled their lower esophageal sphincter and closed, using magnetic attraction, to aid the sphincter in resisting abnormal opening and subsequent reflux. The beads opened with food transport or increased pressure associated with burping or vomiting. Patients' proton-pump-inhibitor dose, frequency of use, quality of life, and foregut symptoms were recorded when the study began and 1 week, 3 months, 6 months, and annually after their operations.
"The primary efficacy end point, normalization of or at least a 50% reduction in esophageal acid exposure, was achieved in 64% of patients (64 of 100; 95% confidence interval [CI], 54 to 73)," Dr. Ganz and colleagues write. "The secondary efficacy end point, a 50% reduction in the quality-of-life score, as compared with the score without proton-pump inhibitors at baseline, was achieved in 92% of patients (92 of 100; 95% CI, 85 to 97)," the authors add.
In addition, after 3 years, 87% of the patients (72/83) had completely stopped using proton-pump inhibitors.
Promising, but Preliminary
Thomas M. Deas Jr, MD, MMM, president of the American Society for Gastrointestinal Endoscopy, told Medscape Medical News that the device appears to be minimally invasive and, depending on its long-term control of symptoms and additional confirmatory trials, could help to treat a condition that affects a growing number of patients. Dr. Deas was not involved in the study.
The study's objective measurement of reduction in acid exposure "was not as impressive" as the subjective measures of patients' symptoms, he says.
"The limitation there is this was not a randomized, controlled study," Dr. Deas told Medscape Medical News. "It's hard, without randomizing patients, to differentiate what is truly a benefit from the intervention and what is perhaps a placebo effect."
The study authors report that 6 patients suffered adverse effects serious enough to require device removal for 4 of them. Overall, device removal was required for 6 patients.
Study limitations included the lack of a control group and a study design that precludes direct comparisons with other therapies. The authors recommend follow-up prospective, randomized trials.
"[T]his single-group trial showed that a magnetic device designed to augment the lower esophageal sphincter can be implanted with the use of standard laparoscopic techniques," the authors conclude. "The device decreased exposure to esophageal acid, improved reflux symptoms, and allowed cessation of proton-pump inhibitors in the majority of patients."
Support for this study was provided by Torax Medical. Thirteen of the 15 study authors disclosed various financial relationships, including receiving institutional grants from, being paid consultants for, receiving travel support from, and owning stock or stock options in Torax Medical and being paid to participate in review activities or to implant the device and perform follow-up visits. One author also disclosed being a paid consultant for EndoGastric Solutions and Covidien. One author disclosed receiving a training fellowship from U.S. Surgical/Covidien. One author disclosed being a paid consultant for Medtronics and Novartis. One author disclosed being a paid consultant for Johnson & Johnson and receiving institutional payments and personal travel expenses for giving lectures for Johnson & Johnson and Lifecell. Four authors disclosed having or expecting personal or institutional grants from Accuray, Covidien, EndoGastric Solutions, GlaxoSmithKline, Johnson & Johnson, Nutricia, Precision Therapeutics, Synovix, and VisionGate. Dr. Deas has disclosed no relevant financial relationships.
N Engl J Med. Published online February 20, 2013. Abstract
Medscape Medical News © 2013 WebMD, LLC
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Cite this: Magnetic Ring Helps Reduce Reflux in Patients With GERD - Medscape - Feb 21, 2013.